Admission for Respiratory Disease And VIdeo Regulation System (ARAVIS-PED)

March 30, 2024 updated by: University Hospital, Grenoble

Pediatric dyspnea is a major health problem, accounting for up to 27% of admissions to emergency departments in winter. It is estimated that a significant number (13%) of patients presenting to emergency departments are outpatients, at a time when emergency departments are having to cope with an ever-increasing flow of patients.

Proper referral of patients calling the SAMU Centre-15 takes on its full meaning in this context, but regulating paediatric calls is more difficult. Indeed, the regulating doctor is most often in contact with the parents, who describe what they see and pass on their concerns, and it is difficult to have direct contact with patients who are often very young. Obtaining objective criteria such as saturation and respiratory rate is also a real challenge.

To overcome the complexity of medical regulation, a number of tools and aids have been developed, including visio or video-regulation (regulation via the camera on the caller's smartphone).

This device has been evaluated in a number of situations, enabling it to take its place in the daily practice of many doctors, but there is very little data concerning pediatric visio-regulation, particularly with regard to dyspnea.

To the best of the investigator knowledge, there is no prospective study looking at the impact of Video-Regulation on the outcome of patients requiring the advice of SAMU Centre-15 for pediatric dyspnea.

Study Overview

Status

Not yet recruiting

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

588

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients included in this study will be children strictly under 10 years of age whose parents have called the SAMU38 for respiratory difficulties.

Therefore, patients who received ambulatory medical advice (with or without instructions to consult a general practitioner within a defined period of time), who were referred to the emergency service by their own means or who benefited from a first-aid vector (fire department or private ambulance) will be included.

Description

Inclusion Criteria:

  • Age strictly less than 10 years
  • Applicant calling the SAMU38 for a child with dyspnea announced or presumed by the interrogation.
  • Patients for whom no opposition from parents has been obtained.
  • Patients affiliated to social security

Exclusion Criteria:

  • Call to organize a secondary intervention (or Inter-Hospital Transfer (TIH/TIIH)).
  • Unsuccessful call (hung up when the dispatcher took the call, without the possibility of medical regulation).
  • Refusal to take charge on arrival of rescue vector
  • Call-back for a patient with an initial call to SAMU38 < 48h
  • Means engaged by the CTA or an ARM even before medical regulation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
No videoregulation
An initial period of 40 days during which we leave the use of video-regulation to the discretion of the regulating physicians (emergency physicians or general practitioners) when they are faced with a call labelled by a medical regulation assistant (ARM) "Pediatric dyspnea in a child under 10 years of age" or when they themselves judge that the call falls into this category; as is the case in the current practice of the SAMU38.
Videoregulation
A 40-day period during which we will encourage regulating physicians to use video-regulation for every call concerning "pediatric dyspnea in a child aged < 10 years".

To encourage the use of video-regulation, several measures will be taken to reinforce its use as much as possible:

  • Posters visible to all in the dispatch room.
  • Regular mailings to all dispatching physicians.
  • On-site presence of interns and the study investigator to help doctors who are not used to video-regulation to get to grips with the computer tool.
  • Involvement of ARMs to remind doctors to use video-regulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine in children under 10 years of age for whom a call to the SAMU38 for dyspnea is made, whether the use of Visio-Regulation reduces the percentage of emergency room admissions compared with standard telephone medical regulation.
Time Frame: 24 hours
Percentage of participants with computerized admission to pediatric emergency departments
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate whether the increased use of video-regulation is not associated with a higher rate of hospitalization in a conventional ward or intensive care unit
Time Frame: 24 hours
Number of patients admitted to hospital or intensive care/resuscitation after emergency admission within 24 hours of the call
24 hours
Evaluate whether the use of video-regulation has an impact on the dispatcher's referral decision between ambulatory medicine and the emergency department.
Time Frame: through call completion, an average of 5 minutes
Percentage of participants among all calls referred to outpatient and inpatient medicine
through call completion, an average of 5 minutes
Determine whether the use of video-regulation leads to an increase in call time with the regulating doctor
Time Frame: through call completion, an average of 5 minutes
Call time spent with the regulating physician
through call completion, an average of 5 minutes
Evaluate parents' satisfaction with videoregulation compared with a standard call
Time Frame: 15 days
Rating of appellants' satisfaction with the decision on a numerical scale from 1 to 5. 1 being the lowest level of satisfaction and 5 being the highest.
15 days
Evaluate the number of rescue vectors (fire brigade, private ambulance) triggered but whose decision will ultimately be to "leave on the spot" after the rescue worker's assessment.
Time Frame: through out-of-hospital care completion, an average of 1 hour
Number of people left behind after a rescue vehicle has been deployed.
through out-of-hospital care completion, an average of 1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 8, 2024

Primary Completion (Estimated)

July 31, 2024

Study Completion (Estimated)

October 18, 2024

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 30, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 38RC23.0376

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pediatric Respiratory Diseases

3
Subscribe